Field of the Invention
The present invention relates to methods for the prevention or treatment of a severe broncho-pulmonary disease by administering a solution formulation from pressurized metered dose inhalers (pMDIs) which is cable of providing therapeutic doses of two or more active drug substances to the lungs, in which substantially all of the liquid particles emitted on actuation of the inhaler contain the two or more active drug substances in a ratio which is substantially the same as a predetermined ratio of the two or more active drug substances in the medicament and the two or more active drug substances are delivered with substantially the same particle size distribution.
Discussion of the Background
Treatment of broncho-pulmonary diseases such as asthma and chronic obstructive pulmonary disease (COPD) with inhaled aerosol drugs offers advantages over systemic therapy, including a more rapid onset and reduced adverse effects, because of the direct targeting of the lungs.
Pressurised metered dose inhalers (pMDIs) are well known devices for administering pharmaceutical products to the respiratory tract by inhalation. MDIs use a propellant to expel droplets containing the pharmaceutical product to the respiratory tract as an aerosol. Formulations for aerosol administration via MDIs can be solutions or suspensions. Solution formulations offer the advantage of being homogeneous, with the active ingredient and excipients completely dissolved in the propellant vehicle or its mixture with one or more suitable co-solvents such as ethanol. Solution formulations also obviate the physical stability problems associated with suspension formulations thereby assuring more consistent uniform dosage administration.
Drugs commonly delivered by inhalation for treating broncho-pulmonary diseases include short-acting and long-acting beta2-agonists, anticholinergics/antimuscarinic agents, and corticosteroids in hydrofluoroalkane (HFA) propellants.
In particular, long-acting β2-agonists (LABAs) such as formoterol and salmeterol and antimuscarinic agents, such as selective muscarinic receptors 3M antagonists, in combination with inhaled corticosteroids (ICS), have been proposed for the prevention and/or treatment of said diseases. However, despite modern maintenance treatments, some patients are still under treated particularly when the broncho-pulmonary disease is in a severe form.
Hence there is still an unmet need for medicaments more efficacious for the prevention or treatment of severe forms of broncho-pulmonary diseases, in particular of sever forms of asthma and COPD.